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Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

Primary Purpose

Vascular Hypotension, Hypovolemia, Hypervolemia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Group
Treatment Group
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Hypotension focused on measuring Goal directed fluid therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management

Exclusion Criteria:

  • Age less than 18;
  • current pregnancy;
  • history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist;
  • patient refusal to consent

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

The control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV.

The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm.

Outcomes

Primary Outcome Measures

Postoperative ileus
Time postoperatively to first bowel movement

Secondary Outcome Measures

Acute kidney injury
Will be measured using the KDIGO criteria (UOP and Cr)
Respiratory compromise
Patients that require oxygen or invasive/non-invasive mechanical ventilation postoperatively
Need for diuresis
Use of a diuretic medication (ex. lasix, metolazone)
Hospital length of stay
Duration of stay in the hospital

Full Information

First Posted
February 6, 2017
Last Updated
April 4, 2018
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03213574
Brief Title
Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients
Official Title
Impact of Goal Directed Fluid Therapy in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator is making changes to the protocol.
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Hypotension, Hypovolemia, Hypervolemia
Keywords
Goal directed fluid therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.
Intervention Type
Other
Intervention Name(s)
Treatment Group
Intervention Description
FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.
Primary Outcome Measure Information:
Title
Postoperative ileus
Description
Time postoperatively to first bowel movement
Time Frame
Up to 3 weeks postoperatively
Secondary Outcome Measure Information:
Title
Acute kidney injury
Description
Will be measured using the KDIGO criteria (UOP and Cr)
Time Frame
Up to 3 weeks postoperatively
Title
Respiratory compromise
Description
Patients that require oxygen or invasive/non-invasive mechanical ventilation postoperatively
Time Frame
Up to 3 weeks postoperatively
Title
Need for diuresis
Description
Use of a diuretic medication (ex. lasix, metolazone)
Time Frame
Up to 3 weeks postoperatively
Title
Hospital length of stay
Description
Duration of stay in the hospital
Time Frame
Up to 4 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management Exclusion Criteria: Age less than 18; current pregnancy; history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist; patient refusal to consent
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

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